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Ampio Pharmaceuticals, Inc. Message Board

  • boatgas1 boatgas1 Jul 23, 2012 9:43 PM Flag

    Ampio: More than meets the eye (2)

    Ampio Pharma's other product candidates include, Zertane, a proposed treatment for life-long premature ejaculation, and Ampion for chronic inflammation.
    Zertane is a specific dose, orally disintegrating tablet formulation of well-known centrally acting opioid pain killer tramadol HCl. This repurposed oral drug is said to have an excellent safety record established during 30 years of human use for other medical indications.
    Zertane has already successfully completed phase III studies in Europe. The drug candidate has 30 use patents issued worldwide. The company is in the process of preparing its regulatory dossier for Zertane and expects to submit the dossier to Therapeutic Goods Administration, the Australian regulatory authority, in late 2012.
    During a pre-IND meeting held in June, the company received clear guidance from the FDA for two concurrent pivotal U.S. trials necessary for approval of Zertane to treat premature ejaculation under the 505(b)(2) regulatory pathway.
    The company plans to commence the pivotal Zertane trials by the end of this year.
    No drug has been approved by the FDA for the treatment of premature ejaculation. Johnson & Johnson's (JNJ) Priligy, a selective serotonin reuptake inhibitor, or SSRI, for treatment of premature ejaculation is approved for sale in Finland, Sweden, Austria, Germany, Italy, Spain and Portugal and the UK.
    Another drug candidate of Ampio Pharma which merits mention is Zertane-ED, a combination product to treat both premature ejaculation and erectile dysfunction. As a first step for the clinical study of Zertane-ED, Ampio Pharma has contracted with Bangalore, India-based Syngene to begin manufacturing (in compliance with FDA standards) the combo product for the conduct of a phase III trial for premature ejaculation and erectile dysfunction in South Korea.
    The company has a license and development agreement with Daewoong Co. Ltd. to market Zertane in South Korea for the treatment of premature ejaculation and for Zertane-ED to be developed for erectile dysfunction.

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